Lead Specialist, Sterilization and Microbiology - Exton, PA

Job description

Lead Specialist, Sterilization and Microbiology Exton, PA: The Lead Specialist, Sterilization and Microbiology will support the maintenance of all sterilization activities for Biomedical manufactured products, the execution of site contamination control policies and procedures, managing environmental monitoring program, providing input to the design of manufacturing processes related to microbiological control, and in producing reports as related to the biosafety of newly developed animal derived products (e.g. viral inactivation studies, zoonosis reports). This role will work in partnership with Supplier Quality Assurance team to drive continual improvement in the sterilization processes and services of Biomedical Exton’s sterilization providers. Key Responsibilities: - Responsible for supporting sterilization activities performed on products manufactured at site, including dose audits and EO requalification assessments - Manage and maintain corporate internal and sub-contracted testing programs for assurance of patient safety including sterile product release and contamination control. - Serve as technical liaison to internal and external laboratory microbiological testing functi...